Charge to the VMAC for the AquAdvantage Salmon Meeting

PRODUCT DEFINITION FOR AQUADVANTAGE SALMON

1. Product IdentityTriploid hemizygous, all-female Atlantic salmon (Salmo salar) bearing a single copy of the α-form of the opAFP-GHc2 rDNA construct at the α-locus in the EO-1α lineage.

2. ClaimSignificantly more of these Atlantic salmon grow to at least 100 g within 2,7000C-day than their comparators.

3. Limitations for UseThese Atlantic salmon are produced as eyed-eggs for grow-out only in the FDA-approved, physically-contained fresh water culture facility.

CHARGE TO THE VMAC

Background:

Generally under the Federal Food Drug and Cosmetic Act, a new animal drug is deemed unsafe unless FDA has approved a new animal dug application for that particular use. Exceptions include where the drug is for investigational use, where the use is off-label and conforms with regulations for such off-label use, or where the drug is conditionally approved or indexed.

The rDNA construct in a GE animal that is intended to affect the structure or function of the body of the GE animal, meets the FFDCA drug definition, and thus would generally be deemed unsafe unless FDA approves that new animal drug.

The approval process involves review of materials presented by a producer (sponsor) as part of a New Animal Drug Application (NADA). The NADA contains relevant information to demonstrate that the regulated article is safe and effective if it is used according to the label.

By “safe” we mean, first, that the article is safe to the animal to which it is administered, which for GE animals bearing heritable rDNA constructs, means the GE animals themselves and, second, that food derived from GE animals is safe, i.e., there is a reasonable certainty of no harm from the consumption of food derived from the GE animals.

“Effective” means the article consistently and uniformly does what the sponsor claims it is supposed to do.

During the NADA process, CVM also considers the article’s impact on the environment; for GE animals this usually involves preparation of an environmental assessment (EA), from which the agency can make a determination as to whether there is likely to be a significant effect on the human environment if the agency approves the application.

QUESTIONS:

Do the data and information demonstrate that the rDNA construct is safe to AquAdvantage salmon?

Do the data and information demonstrate that there is a reasonable certainty of no harm from consumption of foods derived from AquAdvantage salmon?

Do the data indicate that AquAdvantage Salmon grow faster than their conventional counterparts?

Are any potential environmental impacts from AquAdvantage Salmon production adequately mitigated by AquaBounty Technologies’ proposed conditions of use?